Clinical studies are necessary in medicine to measure the effects of healthcare discoveries, including new devices and drugs. Many studies involve numerous patients; locations; doctors; original documents; and study guidelines, both scientific and governmental. In the past, data gathered during clinical studies were collected on paper. Patient charts, drug reactions, and doctor analyses are some examples of information that are parts of a clinical trial. All this information must be collected, verified, and often re-verified several times so that data can be accurately measured, recorded, and compared. In some clinical study management systems, physical documents must then be manually typed into a computer if they are to be accessible in electronic format. This manual input increases the amount of human error in the system.
Verification of this data and other information of the clinical study requires many hours of checking and re-checking, and demands the auditor to be on-site in order to review the documents that are on-site. An auditor would then have to travel to the study location, usually several times for several iterations of auditing. The travel expenses, auditor time, and redundancy required for both of those to ensure data integrity raise costs to an estimated $23 billion each year. Clearly there is a need for a clinical study approach that ensures data integrity while reducing costs.
Similarly, medical charts are stacks of documents that have been written, rewritten, crossed out, initialed, erased, and altogether worn out. A patient chart is passed around from doctor to nurse to administrator and back around again, many times during a patient stay. Research charts are similarly passed around. Printed text becomes difficult to read, signatures and handwriting become illegible, and papers get torn, frayed, and misplaced. There is a need for a medical chart that is authentic, legible, attributable, and easily accessible. Modern clinical studies also demand decreases in the costs of the management and administration; increases in data security and integrity by, among other methods, reducing the amount of human error introduced into the system; and all this while maintaining the active participation of study personnel such as patients and doctors.
Over time, some aspects of clinical studies have been automated. Computers have been used to compile the data after it was already collected manually. Computer software methods have been used to attempt to store structured and unstructured data uniformly. Computers and network communication have opened up the possibility of increased efficiency and capability, but many inefficiencies remain. Repeated verification of source documents is time consuming and often requires reviewing the physical documents personally. Compliance with governmental regulations is often underserved or completely ignored in current automated applications. Information and data is often difficult to transport and communicate to and from a clinical study location. Data and information integrity is often suspect as written documents can be erased or misplaced. Yet information security and integrity are critical aspects of a study that must be carefully planned; and while some technology has attempted to improve upon certain parts of a clinical study, problems exist in verifying the integrity of the data and in the manual processes that remain and that create productivity bottlenecks. There is a need for comprehensively managing a clinical study where efficiency is maximized and verification is easy and inherent.